Evaluating Mindfulness-Based Interventions With New Fibromyalgia Patients

Mayo Clinic

Status: Completed

Conditions: Fibromyalgia

Treatments: Device: Wearable brain sensing wellness device headband system

Study type: Interventional

Funder types: Other

Identifiers

NCT04720053

20-003020

Details and patient eligibility

About

The purpose of this study is to study the feasibility of a wearable brain sensing wellness device to provide mindfulness training to fibromyalgia patients who have failed medical therapy.

Full description

All study participants will receive a wearable brain sensing wellness device, and demonstration of the mindfulness sessions. Participants will be asked to complete study surveys/questionnaires. During the first part of study, participants will be asked to complete the intervention. After completion of the intervention they will enter a follow-Up Phase, where they will be contacted and asked to complete surveys and gauge satisfaction with the study.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or older at time of consent.
• Diagnosed with Fibromyalgia.
• Not pregnant by subject self-report at time of consent.
• Have the ability to provide informed consent.
• Have the ability to complete all aspects of this trial.
• Have access to a iPhone, iPad, Android device.
• Has no contraindicating comorbid health condition as determined by the clinical investigators.

Exclusion criteria

• Used or been enrolled in any treatments for fibromyalgia, or pain within the past 30 days.
• Used an investigational drug within the past 30 days.
• Currently (within the past 3 weeks) been practicing mindfulness training on a weekly/regular basis.
• Currently (within the past 3 weeks) been undergoing an additional program (e.g. CAM) to improve quality of life.
• Currently (within 3 weeks) been enrolled in another clinical or research program (e.g. CAM) which intervenes on the patients' QOL, or stress.
• An unstable medical or mental health condition as determined by the physician investigator.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

Wearable brain sensing wellness device headband system

Experimental group

Description:

Subject diagnosed with fibromyalgia at Mayo Clinic GIM Fibromyalgia Clinic will receive a wearable brain sensing wellness device headband system, and will be given a demonstration of the mindfulness sessions, with detailed instructions on how to begin each session.

Treatment:

Device: Wearable brain sensing wellness device headband system